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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name hemodialyzer with expanded solute removal profile
De Novo Number DEN190042
Device Name Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Requester
baxter healthcare corporation
32650 north wilson road
round lake,  IL  60073
Contact kristen bozzelli
Regulation Number876.5862
Classification Product Code
QAX  
Date Received09/16/2019
Decision Date 08/28/2020
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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